Fat Burn
Conditions
Keywords
Abdominal Fat
Brief summary
The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and four follow-up visits, 1 month, 3, 6 and 12 months after the final treatment. At the baseline visit photographs of the abdomen will be taken. In addition, adipose/muscle layer thickness will be measured with the ultrasound and the subject's weight will be recorded. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in. Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment. Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3, 6 and 12 months after the final treatment. An ultrasound imaging and weight measure will be conducted. Also, subject's satisfaction will be noted. During the first (1 month), third (6 months) and last (12 months) follow-up visits, photographs of abdomen will be taken.
Interventions
The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the abdomen area. Visible contractions will be induced by the device.
Sponsors
BTL Industries Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult subjects of both genders with unwanted abdominal fat and expressing interest in treatment * Age ≥ 22 years * Voluntarily signed informed consent form * BMI ≤ 30 kg/m2
Exclusion criteria
* Cardiac pacemakers * Electronic implants * Pulmonary insufficiency * Metal implants * Drug pumps * Haemorrhagic conditions * Anticoagulation therapy * Heart disorders * Malignant tumor * Fever * Pregnancy * Breastfeeding * Following recent surgical procedures when muscle contraction may disrupt the healing process * Application over menstruating uterus * Application over areas of the skin which lack normal sensation * Scars, open lesions and wounds at the treatment area * Unrepaired abdominal hernia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of the device assessed through photographic evaluation | 13 months | Photographic evaluations with correct identification of pre-treatment images compared to post-treatment images. |
| Effectiveness of the device assessed through change in adipose layer thickness | 13 months | Change in adipose layer thickness between pre-treatment and post-treatment based on ultrasound measurements |
| Subject's satisfaction | 13 months | The 5-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results. Subjects will be evaluating agreement with three different statements (concerning satisfaction with therapy results and appearance of abdominal area after therapy) by choosing an answer on a scale between 1 (Strongly disagree) and 5 (Strongly agree). Minimally 80% of the treated subjects should report the agreement with all three statements given in the questionnaire (answers Agree and Strongly agree) in order to claim subject's satisfaction with the therapy outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the device for non-invasive fat disruption | 13 months | The secondary objective of the study is to determine side effects and adverse events (AE) associated with the treatment of the abdominal area. The occurrence of adverse events will be followed throughout the whole study. |
| Therapy comfort | 3 months | Therapy comfort will be noted at the last therapy visit. |
Countries
Bulgaria, United States
Outcome results
None listed